Millions of medications are compounded each year in the US to meet the unique needs of patient, including vulnerable populations such as seniors and children. Compounding provides tailored therapy to patients who may not be able to use commercially available formulations due to dosing requirements, allergies or rare diseases.

Compounded drugs made without the guidance of standards may be sub-potent, super potent or contaminated, exposing patients to significant risk of adverse events or even death.

May 1, 2018 - <795> will be formally published in the Pharmacopeial Forum

July 31, 2018 - Public Comment Period for <795> will close

June 1, 2019 - Intended Publication Date of <795> in USP–NF

December 1, 2019 - Anticipated Official Date for <795>

* The current published version of General Chapter <795> in USP-NF is official until the new Chapter becomes official.
** The proposed revision to <795> is pre-posted in advance of its publication in Pharmacopeial Forum (PF) 44(3) [May.-Jun. 2018] to allow additional time for public comment and review.

Developing USP General Chapter <795>

USP is a not-for-profit, science-driven organization that has an established process for convening independent experts for the development and maintenance of healthcare quality standards. The process is public health focused, leveraging current science and technology, and draws on the expertise of scientists and healthcare practitioners while providing opportunities for public input from stakeholders throughout the standard setting process.

Stay Involved: Stakeholder Engagement

Public comment is integral to the standard setting process. During standard development, USP seeks to obtain input from stakeholders such as patients, healthcare practitioners, policymakers, academicians, and industry, to ensure that broad perspectives are included in the standard.